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NCT Number: NCT06174038

Early Age-Related Hearing Loss Investigation (EARHLI)

Early Age-Related Hearing Loss Investigation (EARHLI) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education intervention. Participants will be followed for 1 year. This study will provide information on reducing cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD).

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Ear Diseases Hearing Disorders Hearing Loss Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tauopathies

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Justin S Golub, MD

PRINCIPAL_INVESTIGATOR

Larry Tapia

CONTACT

[email protected]

646-317-3252

About this study

EARHLI will be a phase II 1:1 randomized controlled trial of a hearing intervention (including prescription hearing aids) versus a health education program. Participants must be 55-75 years old and have early-stage age-related hearing loss and amnestic mild cognitive impairment. The trial will last 1 year and occur at a single site (Columbia University Irving Medical Center). Outcome measurements will include cognition, social engagement, and change in brain organization/connectivity. Assessments will occur at study start, 6 months, and 12 months. A total of 150 participants will be enrolled (75 per intervention group). Participants will also have a hearing test and a blood test. Approximately half of participants will have two MRI scans. As part of participating, all participants will get prescription hearing aids, either at study start or end.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 55-75 years of age
  • Adult-onset hearing loss of approximately mild to moderate in severity (4-frequency 0.5, 1, 2, 4 kHz pure tone average 20 dB to 55 dB HL in better hearing ear)
  • Aidable hearing loss, defined by word recognition score in quiet ≥ 60% in better hearing ear
  • Amnestic mild cognitive impairment (MCI) defined by Mini-Mental State Exam (MMSE2) score >23, Clinical Dementia Rating (CDR) global score equivalent = 0.5, and ADNI3 criteria of Logical Memory II score of ≤6 if 0-7 years of education, ≤9 if 8-15 years, and ≤11 if ≥16 years
  • Availability of a study partner (informant) for the administration of the cognitive screen and the ADCS-Activities of Daily Living-Prevention Instrument (ADCS-ADL-PI)
  • Community-dwelling
  • Fluent in English or Spanish
  • Availability of participant in area for study duration

Exclusion criteria

  • Self-reported congenital hearing loss, known genetic mutation-related hearing loss, or hearing loss onset before middle age (<45 years old)
  • Prior dementia diagnosis
  • Reported disability in ≥ 2 activities of daily living (ADLs)
  • Current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials)
  • Unwillingness to wear hearing aids regularly (≥8 hours/day)
  • Medical contraindications to the use of hearing aids (e.g., actively draining ear)
  • Corrected vision impairment (worse than 20/63 on MNRead Acuity Chart in worse eye)
  • Untreatable conductive hearing loss with air-bone gap > 15 dB in two or more contiguous octave frequencies in both ears

Treatment and study plan

Hearing Intervention

Device

The hearing intervention includes an auditory needs assessment, hearing aid fitting, establishing Bluetooth connectivity from hearing aids to devices such as smartphones and computers, systematic orientation and instruction in device use, and provision and discussion of hearing "toolkit" materials for self-management and communication strategies. The hearing intervention is person-centered, focusing on identification of individual needs, setting of specific goals, engagement in shared-informed decision-making, and development of self-management abilities. Intervention-centric outcomes (e.g., hearing aid data logging, real ear measures) to verify the best-practices intervention will be gathered at all 5 intervention sessions as well as weeks 16 and 52. Additional visits to troubleshoot hearing aids or address concerns will be scheduled as needed.

Health education intervention

Behavioral

The evidence-based interactive health education program is designed for older adults and addresses chronic disease and disability prevention. Session content will be individualized for each participant based on a "key," depending on his/her goals/interests. The curriculum includes didactics, activities, and goal setting led by staff trained/certified to deliver the intervention.

Primary outcomes

  1. Free and Cued Selective Reminding Test (FC-SRT) Score

    Time frame: Week 0, Week 28, Week 52

    This is the Cognitive Performance Test # 1 ADCS-PACC 1: Evaluates Episodic Memory. Scoring from 0 - 48 and a higher score translates into a preserved function of the episodic memory.

  2. Delayed Recall Log Memory IIa, (DRLM) Score

    Time frame: Week 0, Week 28, Week 52

    This is the Cognitive Performance Test # 2 ADCS-PACC 2: Evaluates Episodic Memory. Scoring from 0 - 25 and a higher score translates into a preserved function of the episodic memory.

  3. Digit Symbol Substitution Test, (DSST) Score

    Time frame: Week 0, Week 28, Week 52

    This it the Cognitive Performance test # 3 ADCS-PACC 3: Evaluates speed of processing. Scoring from 0 - 91 and a higher score relates to better performance and speed of processing.

  4. Mini-Mental State Examination 2, (MMSE-2) Score

    Time frame: Week 0, Week 28, Week 52

    This is the Cognitive Performance test # 4 ADCS-PACC 4: Evaluates Global Cognition. Scoring from 0 - 30 and a higher score relates to preserved Global Cognition.

  5. Trail Making Test Part B, (TMTB) Score

    Time frame: Week 0, Week 28, Week 52

    This is the Cognitive Performance test # 5 Evaluates Episodic Memory. Scored in terms of the time, in seconds, required to complete the trail. 300 seconds = maximum amount of time. The less seconds it takes to complete the trail, the better performance/ episodic memory.

  6. Activities of Daily Living for Mild Cognitive Impairment, (ADCS-ADLPI) Score

    Time frame: Week 0, Week 28, Week 52

    This is the Cognitive Performance test # 6: Evaluates the ability of patients to perform Activities of Daily Living. Section a. Scored from 0 - 45: Items 1 to 15. Higher score for each activity equals better performance. Section b. Scored from 0 - 5. Item 16 to 20. Higher score equals better performance

  7. Social Activity Frequency

    Time frame: Week 0, Week 28, Week 52

    This is the Social Engagement and Related Socialization test # 1: Evaluates frequency of social activity participation. Participants are asked on a 5-point scale how often during the past 6 months they engaged in 6 common activities involving socialization. A composite score is created

  8. Ability to Participate in Social Roles and Activities (APSR) Score

    Time frame: Week 0, Week 28, Week 52

    This is the Social Engagement and Related Socialization test # 2: Evaluates Social Activity Participation. Scored from 8 - 40 a higher score translates into higher levels of social participation.

  9. Community Integration Measure (CIM) Score

    Time frame: Week 0, Week 28, Week 52

    This is the Social Engagement and Related Socialization test # 3: Evaluates Community Integration/Participation. Scored from 10 - 50. Higher scores indicate higher levels of community integration and participation.

  10. Cohens Social Network Index (SNI) Score

    Time frame: Week 0, Week 28, Week 52

    This is the Social Engagement and Related Socialization test # 4: Evaluates Social Relationships. Scored from 1 - 12. Higher score indicates a larger number of social roles in which the respondent has regular contact.

  11. University of California Loneliness Scale (ULS) Score

    Time frame: Week 0, Week 28, Week 52

    This is the Social Engagement and Related Socialization test # 5: Evaluates Individuals perception of loneliness. The total score ranges from 20 - 80. Higher scores indicate higher loneliness.

  12. Brain MRI Measures

    Time frame: Week 0, Week 52

    Approximately 50% of all participants (random selection) will have a functional brain MRI.

Other outcomes

  1. Hearing Handicap Index for Adults and the Elderly-Short (HHIS) Score

    Time frame: Week 0, Week 28, Week 52

    This test evaluates self perceived hearing handicap. Score ranges from 0 - 48, a higher score indicates higher perception of problems secondary to hearing loss.

  2. Hearing Handicap Index-Short-Significant Other (HHIO) Score

    Time frame: Week 0, Week 28, Week 52

    This test evaluates hearing handicap perceived by subjects significant other. Score ranges from 0 - 48, a higher score indicates higher perception of problems secondary to hearing loss.

  3. Speech, Spatial and Qualities of Hearing Scale (SSQ12) Score

    Time frame: Week 0, Week 28, Week 52

    This test evaluates a range of hearing disabilities across several domains. Scored from 0 - 120, a higher score indicates better hearing.

  4. Vanderbilt Fatigue Scale (VFS) Score

    Time frame: Week 0, Week 28, Week 52

    This test evaluates listening-related fatigue in individuals with hearing loss and other communication-based difficulties. Scored from 0 - 40, a higher score indicates more symptoms of fatigue related to hearing loss.

  5. Pittsburgh Fatigability Scale (PFS) Score

    Time frame: Week 0, Week 28, Week 52

    This test evaluates self-report whole-body physical and mental tiredness related to activities of fixed intensity and duration in adults. Scored from 0 - 50, a higher score indicates more symptoms of fatigue.

  6. Quick Inventory of Depressive Symptoms (QIDS) Score

    Time frame: Week 0, Week 28, Week 52

    Assesses the 9 criterion domains used to diagnose a depressive disorder. Scored 0 - 27 This is the Depression/Depressive Symptom Measure #1: Higher score indicates the presence of more depressive symptoms.

  7. CESD-12 Depression (CES) Score

    Time frame: Week 0, Week 28, Week 52

    This is the Depression/Depressive Symptom Measure # 2: Evaluates symptoms of depression. Possible range of scores is 0 -26, with the higher scores indicating the presence of more symptomatology

  8. RAND Short-Form 36 (SF36)

    Time frame: Week 0, Week 28, Week 52

    This is a general measure of quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Larry Tapia

CONTACT

[email protected]

646-317-3252

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Johns Hopkins University
  • National Institute on Aging (NIA)
  • University of Pittsburgh
  • University of South Florida
  • University of Washington

Registry information

Official study title

Early Age-Related Hearing Loss Investigation (EARHLI): A Randomized Controlled Trial to Assess the Mechanisms Linking Early Age-Related Hearing Loss and Alzheimer's Disease and Related Dementias

Acronym: EARHLI

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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